FDA Issues Guidance on New Medical Device Shortage Reporting Requirements

To help our clients navigate the coronavirus (COVID-19) crisis, Arnold & Porter has established a Coronavirus Task Force covering a wide range of issues and challenges. Subscribe to our "Coronavirus (COVID-19)" mailing list to receive our latest client Advisories and register for upcoming webinars.

*          *          *          *          *

Introduction

On May 6, 2020, the Food and Drug Administration (FDA or the Agency) issued written guidance (the Guidance) implementing a provision of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that requires manufacturers to report certain medical device shortages.¹ As discussed in greater detail below, the Guidance clarifies and makes recommendations for medical device manufacturers regarding three major notification requirements: (1) which device manufacturers must notify FDA, (2) when to do so, and (3) what information to include. The Guidance takes immediate effect and is intended to remain in effect only for the duration of the COVID-19 pandemic. It remains subject to public comment, and comments may be submitted at any time for Agency consideration.² This new reporting requirement supplements similar, preexisting reporting requirements for shortages of pharmaceutical drugs and biologics that were in place before the COVID-19 pandemic. For more information on reporting requirements for pharmaceuticals and biologics, please see Arnold & Porter's previous Advisory on the subject.

Background

The FDA previously expressed concerns that "[n]o law requires medical device manufacturers to notify FDA when they become aware of a circumstance that could lead to a device shortage."³ Indeed, even before the COVID-19 pandemic, the Agency had sought legislation to "require all manufacturers of devices determined to be essential to periodically provide FDA with information about the manufacturing capacity of the essential device(s) they manufacture."⁴

Prompted by the severe shortages caused by the pandemic, the CARES Act, which was signed into law on March 27, 2020, added section 506J to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This new section provides FDA with authorities to prevent or mitigate medical device shortages before or during a public health emergency. To that end, the provision includes requirements for manufacturers of certain medical devices deemed critical to public health to notify FDA "of a permanent discontinuance in the manufacture of the device" or "an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in supply of that device in the United States"⁵ during a public health emergency. The Guidance now offers additional clarity on how manufacturers can comply with those requirements.

The Guidance is intended to facilitate timely disclosures to FDA and help the Agency prevent or mitigate any potential medical device shortages during the COVID-19 health emergency. The Guidance clarifies and makes recommendations regarding three major notification requirements: (1) who must notify FDA, (2) when to notify FDA, and (3) what information to include in notifications.

Which Device Manufacturers Must Notify FDA?

Section 506J of the FD&C Act requires manufacturers of two broad categories of products to notify FDA of interruptions or permanent discontinuances in manufacturing: (1) medical devices that are critical to public health during a public health emergency; or (2) medical devices for which FDA determines information on potential significant supply disruptions is needed during a public health emergency.⁶ For purposes of the Guidance, FDA interprets the term "manufacturer" to mean the entity that holds the medical device marketing submission authorization; if a medical device marketing submission is not required, the "manufacturer" is the entity responsible for listing the medical device under section 510(j) of the FD&C Act.

The Guidance further clarifies that devices described above with marketing authorization from FDA, or that are listed under section 510(j) of the FD&C Act (which requires that registered firms list with FDA all devices they currently market), are subject to the notification requirements established by section 506J. However, a device for which FDA clearance is required prior to marketing, but that is being distributed pursuant to FDA guidance providing enforcement discretion during the COVID-19 health emergency, is not subject to the notification requirements.⁷

Notifications are overseen by FDA's Center for Devices and Radiological Health (CDRH). FDA recommends that manufacturers consider the following criteria in determining whether they are required to submit notification to CDRH:

• Whether the device (with or without accessories) is life-supporting, life-sustaining, or intended for use in emergency medical care (e.g., ventilators and ventilator tubing, hemodialysis equipment, automated external defibrillator);
• Whether the device (with or without accessories) is intended for use during surgery (e.g., cardiopulmonary bypass oxygenators, infusion pumps and tubing);
• Whether the device (with or without accessories and/or testing supplies) is used to diagnose, cure, treat, mitigate or prevent COVID-19 (e.g., specific supplies from diagnostic and serological specimen collection kits, reagents for extraction or PCR amplification or serological testing, pulse oximeters, cardiac and other monitoring equipment); or
• Whether the device (with or without accessories) would be in higher-than-typical demand during the response to the COVID-19 pandemic compared to a similar period of time (e.g., personal protective equipment).⁸

The Agency further recommends that manufacturers uncertain whether to notify FDA about a device should contact the Agency.

When Should FDA Be Notified?

To provide FDA with sufficient time to address potential shortages of medical devices, section 506J of the FD&C Act requires manufacturers to notify FDA at least six months in advance of a permanent discontinuance or a manufacturing interruption that is likely to lead to a meaningful disruption in supply of the device. However, when such notice is impossible, manufacturers can notify FDA "as soon as practicable." Section 506J defines "meaningful disruption" as "a change in production that is reasonably likely to lead to a reduction in the supply of a device by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product."⁹

The Guidance clarifies that for the duration of the COVID-19 health emergency, FDA will interpret key provisions of section 506J as follows:

• "As soon as practicable" is no later than seven calendar days after a discontinuance or interruption in manufacturing.¹⁰
• A "meaningful disruption" is based on a manufacturer's own capacity, supply, and orders, and should not take into consideration other manufacturers' or competitors' capacities or assumed capacities, or what the manufacturer understands about market demand for the device.¹¹
• "Interruptions in manufacturing" include those that occur from a decrease in manufacturing capability or increased demand.¹²

Additionally, FDA requests immediate notification if a manufacturer considers taking an action that may lead to a meaningful disruption in the supply of a device, or if a manufacturer is ordered by another American government entity to take an action that diverts supply from its original customer. To help FDA monitor the supply of critical medical devices during the current health emergency, the Guidance recommends that manufacturers provide the Agency with voluntary status updates every two weeks until the risk of disruption or shortage has been resolved.¹³

What Information Should be Included in Notification?

In addition to section 506J(a)'s broad requirement that medical device manufacturers notify FDA of "the reasons" for any potential discontinuance or manufacturing interruption, FDA also seeks the following information:

• Appropriate identifying information (e.g., marketing submission holder name, marketing submission number, manufacturer name, FDA Establishment Identifier (FEI) number, device name, product code, and contact information);
• Reason(s) for discontinuance or interruption;
• Duration of discontinuance or interruption;
• Details regarding how COVID-19 has impacted the ability to manufacture and/or distribute the device;
• Potential mitigation actions; and
• Production capacity and market share details.¹⁴

In light of the current health emergency, the above notification should be submitted to CDRH regardless of whether all requested information is fully available to the manufacturer. Notifications can be updated at any time to include additional information.¹⁵

Conclusion

The COVID-19 health emergency has emphasized the importance of mitigating potential medical device shortages, and this Guidance clarifies important new reporting requirements under section 506J of the FD&C Act. Medical device manufacturers should put formal procedures in place to ensure compliance with these new requirements. We expect FDA to issue additional guidance on the expanded requirements for drug shortage reporting established by the CARES Act. We will continue to monitor developments in this area and to assist clients in understanding and complying with these new guidelines.

© Arnold & Porter Kaye Scholer LLP 2020 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.